Post-operative DeliriumBISCARNCT05877326
Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention
A study testing General anesthesia with propofol or sevoflurane and CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative in people with Post-operative Delirium and Anaesthetic Depth, run by Centre Cardiologique du Nord at 1 site in France.
Trial summary
Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years. The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or… Read more about this study
- Who is it for?
- Ages 75 to 85 years
- Conditions the study is for
- Post-operative Delirium, Anaesthetic Depth
- What is being tested?
- General anesthesia with propofol or sevoflurane and CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged between 75 and 85 years, who signed an informed consent, undergoing elective valvular, coronary artery bypass, aortic or combined cardiac surgery
- Be affiliated to French Health Insurance
Who cannot join
- Refusal of consent -Patient unable to read, write or understand French
- Vulnerable patient according to article L1121-6 of the CSP,
- Patient of legal age under guardianship or curatorship or under legal protection,
- Patient unable to give personal consent according to article L.1121-8 of the CSP or adult protected by law,
- Patient having already participated in the present study
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years.
The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting.
Read more
The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects.
Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms :
- Perioperative anesthesia with a BIS (Bispectral index) target of 35
- Perioperative anesthesia with a BIS(Bispectral index) target of 55
The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure.
Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ).
Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .
Read the detailed description
Multicenter, controlled, randomized trial with two parallel arms (Perioperative anesthesia with a BIS target of 35 / Perioperative anesthesia with a BIS target of 55).
Randomization will be stratified by center, type of surgery (valve vs coronary artery bypass surgery vs aortic surgery vs combined surgery), patient age (75-80 vs 81-85), Euroscore 2 score at inclusion (predicted mortality risk ≥ vs < to 30%).
An ancillary study with MOCA score measurement at inclusion, discharge and 3 months after cardiac surgery will be realized.
Primary Objective:
To demonstrate the benefit of lower anesthesia on the prevalence of delirium during the first 3 days postoperatively in patients aged 75 years and older having cardiac surgery (valvular, coronary bypass, aortic or combined surgery).
Primary endpoint:
Presence of mental confusion will be determined by CAM-ICU at day 3 post surgery.
The CAM-ICU is considered POSITIVE (confusion present) if criteria 1 and 2 + 3 or 4 are met.
Secondary objectives:
To evaluate the effects of the intervention on ICU and hospital length of stay, delirium durations, mortality at month 3 , prevalence of POD during the stay, duration of mechanical ventilation, rate of reintubation,total amount of propofol, opioids and neuromuscular blockade (au lieu de curares) during anesthesia .
Secondary endpoints:
CAM ICU at times day 1, Day 2 , and Day 3 , daily doses of benzodiazepines, opiates, propofol, dexmedetomidine, and neuroleptics, days without mechanical ventilation, ICU and total lengths of stay, vital status (phone call) at Month 3, duration of delirium, total amount of propofol, opioids and neuromuscular blockade during anesthesia .
In order to demonstrate a minimum difference in the confounding rate (according to CAM-ICU) of 20 points (50% expected in the BIS 35 arm versus 30% in the BIS 55 arm) and with a two-sided first-species risk of 5% and a minimum power of 80%, 186 analyzable subjects (93 per arm) are required.
In order to take into account possible loss of sight, we propose to include in this study a total of 200 subjects (100 per arm).
- Conditions
- Post-operative Delirium, Anaesthetic Depth
- Being tested
- General anesthesia with propofol or sevoflurane, CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia with propofol or sevofluraneDrug
Also called General anesthesia with 35 BIS target or 55 BIS target
General anesthesia
CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operativeBehavioural
The presence of mental confusion will be determined by CAM-ICU at J3 post intervention.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative anesthesia with a BIS target of 35 | Active comparator | Anesthesia with a BIS target of 35 Receives: Drug: General anesthesia with propofol or sevoflurane; Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative |
| Perioperative anesthesia with a BIS target of 55 | Active comparator | Anesthesia with a BIS target of 55 Receives: Drug: General anesthesia with propofol or sevoflurane; Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the benefit of reduced depth of anesthesia
The presence of mental confusion using CAM-ICU ( The Confusion Assessment Method for the Intensive Care Unit )
Measured: Day 3 post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study startSep 2023 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, controlled, randomized, two parallel-arm trial: Perioperative anesthesia with a BIS target of 35 Perioperative anesthesia with a 55% BIS target
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellouze Omar, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877326
- Sponsor's protocol ID
- 2022-A02200-43
- Acronym
- BISCAR
- Status last verified
- Jun 2023
- First submitted
- 2 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor and the persons acting on its behalf will have access to the data. In addition, only the persons delegated by the investigating physician, health or research professionals, involved in the realization of the research and subject to professional secrecy, will have access to these coded data.
Publications
Ellouze O, Zogheib E, Abdelhafidh K, Lemaire A, Berger J, Charfeddine A, Bouzguenda H, Konstantinou M, Molinari N, Bonnet N, Geri G, Nappi F. Anaesthetic depth and short-term delirium after cardiac surgery intervention: the study protocol of the BISCAR multicentre randomised clinical trial. BMJ Open. 2025 Aug 28;15(8):e103105. doi: 10.1136/bmjopen-2025-103105.
PubMed 40876878
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention
- ClinicalTrials.gov ID
- NCT05877326
- Acronym / sponsor ID
- BISCAR / 2022-A02200-43
- Conditions
- Post-operative Delirium, Anaesthetic Depth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years.
The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting.
The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects.
Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms :
- Perioperative anesthesia with a BIS (Bispectral index) target of 35
- Perioperative anesthesia with a BIS(Bispectral index) target of 55
The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure.
Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ).
Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .
Detailed description
Multicenter, controlled, randomized trial with two parallel arms (Perioperative anesthesia with a BIS target of 35 / Perioperative anesthesia with a BIS target of 55).
Randomization will be stratified by center, type of surgery (valve vs coronary artery bypass surgery vs aortic surgery vs combined surgery), patient age (75-80 vs 81-85), Euroscore 2 score at inclusion (predicted mortality risk ≥ vs < to 30%).
An ancillary study with MOCA score measurement at inclusion, discharge and 3 months after cardiac surgery will be realized.
Primary Objective:
To demonstrate the benefit of lower anesthesia on the prevalence of delirium during the first 3 days postoperatively in patients aged 75 years and older having cardiac surgery (valvular, coronary bypass, aortic or combined surgery).
Primary endpoint:
Presence of mental confusion will be determined by CAM-ICU at day 3 post surgery.
The CAM-ICU is considered POSITIVE (confusion present) if criteria 1 and 2 + 3 or 4 are met.
Secondary objectives:
To evaluate the effects of the intervention on ICU and hospital length of stay, delirium durations, mortality at month 3 , prevalence of POD during the stay, duration of mechanical ventilation, rate of reintubation,total amount of propofol, opioids and neuromuscular blockade (au lieu de curares) during anesthesia .
Secondary endpoints:
CAM ICU at times day 1, Day 2 , and Day 3 , daily doses of benzodiazepines, opiates, propofol, dexmedetomidine, and neuroleptics, days without mechanical ventilation, ICU and total lengths of stay, vital status (phone call) at Month 3, duration of delirium, total amount of propofol, opioids and neuromuscular blockade during anesthesia .
In order to demonstrate a minimum difference in the confounding rate (according to CAM-ICU) of 20 points (50% expected in the BIS 35 arm versus 30% in the BIS 55 arm) and with a two-sided first-species risk of 5% and a minimum power of 80%, 186 analyzable subjects (93 per arm) are required.
In order to take into account possible loss of sight, we propose to include in this study a total of 200 subjects (100 per arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, controlled, randomized, two parallel-arm trial: Perioperative anesthesia with a BIS target of 35 Perioperative anesthesia with a 55% BIS target
| Arm | Type | Receives |
|---|---|---|
| Perioperative anesthesia with a BIS target of 35 | Active comparator | Drug: General anesthesia with propofol or sevoflurane, Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operativeAnesthesia with a BIS target of 35 |
| Perioperative anesthesia with a BIS target of 55 | Active comparator | Drug: General anesthesia with propofol or sevoflurane, Behavioral: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operativeAnesthesia with a BIS target of 55 |
Who may qualify
- Ages
- 75 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient aged between 75 and 85 years, who signed an informed consent, undergoing elective valvular, coronary artery bypass, aortic or combined cardiac surgery
- Be affiliated to French Health Insurance
Key exclusion criteria (5 listed)
- Refusal of consent -Patient unable to read, write or understand French
- Vulnerable patient according to article L1121-6 of the CSP,
- Patient of legal age under guardianship or curatorship or under legal protection,
- Patient unable to give personal consent according to article L.1121-8 of the CSP or adult protected by law,
- Patient having already participated in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesia with propofol or sevofluraneAlso: General anesthesia with 35 BIS target or 55 BIS targetGeneral anesthesia | Drug | Perioperative anesthesia with a BIS target of 35, Perioperative anesthesia with a BIS target of 55 |
| CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operativeThe presence of mental confusion will be determined by CAM-ICU at J3 post intervention. | Behavioural | Perioperative anesthesia with a BIS target of 35, Perioperative anesthesia with a BIS target of 55 |
Primary outcome
To demonstrate the benefit of reduced depth of anesthesia
Time frame: Day 3 post intervention.
The presence of mental confusion using CAM-ICU ( The Confusion Assessment Method for the Intensive Care Unit )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 40876878Ellouze O, Zogheib E, Abdelhafidh K, Lemaire A, Berger J, Charfeddine A, Bouzguenda H, Konstantinou M, Molinari N, Bonnet N, Geri G, Nappi F. Anaesthetic depth and short-term delirium after cardiac surgery intervention: the study protocol of the BISCAR multicentre randomised clinical trial. BMJ Open. 2025 Aug 28;15(8):e103105. doi: 10.1136/bmjopen-2025-103105.
- Individual participant dataSharing planned: No. The sponsor and the persons acting on its behalf will have access to the data. In addition, only the persons delegated by the investigating physician, health or research professionals, involved in the realization of the research and subject to professional secrecy, will have access to these coded data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellouze Omar, MD principal investigator
Centre Cardiologique du Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia with propofol or sevoflurane and CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative in people with Post-operative Delirium and Anaesthetic Depth, run by Centre Cardiologique du Nord at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellouze Omar, MD (0149337245, ellouze.omar@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the benefit of reduced depth of anesthesia (time frame: Day 3 post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.